Cysview

Cysview (hexaminolevulinate hydrochloride) is an imaging drug used in the cystoscopic detection of non-muscle invasive papillary cancer of the bladder among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy. Cysview is used with the Karl Storz D-Light C Photodynamic Diagnostic (PDD) system to perform cystoscopy with the blue light setting (Mode 2) as an adjunct to the white light setting (Mode 1).

Common side effects of Cysview include:

• bladder spasm,
• pain during urination,
• difficulty urinating,
• blood in the urine,
• inability to empty the bladder,
• bladder pain, or
• headache.

For bladder instillation only

Recommended Dose

The recommended dose for adults is 50 mL of reconstituted solution of Cysview (hexaminolevulinate hydrochloride intravesical solution) (2.2), instilled into the bladder via a urinary catheter (2.3).

• There are no available data on Cysview use in pregnant women to inform a drug associated risk of adverse developmental outcomes.
• Adequate reproductive and developmental toxicity studies in animals have not been performed. Systemic absorption following administration of Cysview is expected to be minimal.
• There are no data on the presence of hexaminolevulinate in human or animal milk, the effects on a breastfed infant, or the effects on milk production. Systemic absorption following administration of Cysview is expected to be minimal.
• The lack of clinical data during lactation precludes a clear determination of the risk of Cysview to an infant during lactation; therefore, the development and health benefits of breastfeeding should be considered along with the mother's clinical need for Cysview and any potential adverse effects on the breastfed infant from Cysview or from the underlying maternal condition.